Lab mistakes….how do they happen?

May 19, 2010Carole 6 Comments »

My Dad is retired and loves the internet. He often sends me articles he likes from the New York Times and other news outlets. This morning he sent me the story of Shannon Morell, an infertility patient who just published her book “Misconception” about her family’s horrible experience with a fertility lab error. Her frozen embryo was thawed and transferred to another woman who became pregnant. Her story ended well, in the sense that the other patient, Carolyn Savage, who received the embryo decided to carry the embryo to term for Shannon and her husband and gave the child back to the Morells when the boy was born.  Carolyn Savage’s selfless act was incredibly brave and generous.

I haven’t read “Misconception” yet but you can bet I will. When these disasters happen and they do, it’s always the same question, “How could this possibly happen?” As an embryologist, I need to know how errors happen but more importantly, how to prevent them from happening.  Embryologists talk about these disasters and how to prevent them when they get together. I am not particularly religious myself, but I still feel like I should cross myself to ward off evil to even talk about these things. Worries that something MIGHT have gone wrong or been forgotten is the fear that wakes up embryologists in the middle of the night, in a cold sweat with a pounding heart.

I think there are some similarities between embryologists and air traffic controllers. Both jobs have zero tolerance for error. Both jobs have catastrophic consequences when errors do occur. Microscopic eggs and embryos are moved around between points of visibility (when they are under a microscope) using glass pipettes and other tools. When they are in the pipette and moving to a second dish, we can’t see them. Until we expel them into the dish and see them under the microscope again, they are invisible. It’s not like holding something in your hand that you can see all the time.  Planes go on and off the radar screen. Bad things happen when you can’t see what’s going on. Embryologists make these microscopic transfers all day long in busy clinics. We transfer eggs and embryos to wash them, clean them, fertilize eggs and change them to fresh medium. All day long, microscopic specimen are going on and off the radar screen.

Also, eggs and embryos don’t come labeled. Your eggs and embryos look just like everybody elses, same size, same color, no matter ethnicity, race, gender. All the same. The container they are in tells us who they belong to. Labeling correctly is everything. Tracking that label is critical. Chain of custody is critical.

Okay, so given this landscape, how do we prevent errors? Actually, a lot can be done and is done in good labs to prevent errors.

Hiring the right technicians and enough of them. When I last hired an embryologist for the lab, I got hundreds of applicants with no lab experience who thought the job would be so cool. All those applications went right into the trash. What I want is a detail oriented person with general lab experience that I can train, a confident perfectionist who is just short of clinical OCD. I want them to be very motivated to work as perfectly as possible. I want someone who can follow the protocols the same way every time. If my protocol is bad and things happen, that’s my fault. If the protocol is good and the techs don’t follow it, bad things that happen are their fault. I also want people who can work as part of a team. We have to be able to depend on each other and back each other up when someone is sick or having a bad day.

I have a real beef with programs who hire based on the number of cases they have instead of patient safety. Some small programs rely on one lab tech to do all the embryology because they think they can’t afford to hire a second lab tech.  When you factor in the costs of a lab lawsuit, having a back-up tech starts to look like a bargain. Having only one lab tech is a terrible idea for so many reasons. If your one lab tech get sick, guess what, they’re still coming to work, even if they are feverish and puking. Because there is NO ONE ELSE to do their job and they’ll get all kinds of hell if a cycle needs to be cancelled. Embryologists are so highly trained, you can’t just hire a clinical lab tech from the hospital to fill in for the day. Imagine yourself at work, sick. We’ve all been there. Now imagine your embryo air traffic controller who is sick. Lots of attention to detail work that requires clear mental focus. That day’s work might not go so well.

The other reason it is critical to have more than one tech in the lab is that chain of custody protocols require that a second person stand by and observe and agree (and document) that the sample is labeled right, that the right egg and sperm are going together and that the right embryo is going back to the right person. I don’t know a single embryologist who doesn’t want this double check system. We want to have a buddy to check ourselves against. If we catch an error before the procedure happens, we prevent the error. Embryologists sleep better when redundant systems are in place.

Once I have hired a new tech, it typically takes two years before they are fully trained. They typically start by learning hot to perform low risk tasks like semen analysis. Then, they gradually move up to more technically challenging skills. Also, lots and lots of hands on training with moving embryos around using animal embryos or abnormal non-viable embryos that patients have generously donated to us for technical training. Thank you to these generous patients!!

Labeling samples correctly is critical. We label paperwork, dishes, test tubes, pipettes. Everything we use for your case has your identity on it. The Shannon Morrell mix-up happened because they matched the embryo to transfer to the patient based on last name only. Shannon’s maiden name was Savage. Using last name only is a terrible idea. Even working in small to medium sized programs, it was amazing how often patients with the same or nearly the same last name came through during the same treatment period. If we’d relied on last name only, we’d have gotten ourselves in trouble. Three identifiers are commonly used, first and last name, date of birth and a unique identifier number  assigned to the patient. Also, we often see couples with different last names so matching by last name is not even possible.

What you label is also important. Culture dishes have a lid. I have heard stories of places where they label the lid and not the bottom. Guess what, that lid comes off to do the work and now the container with your embryos in it is unlabeled. Very bad idea. Embryologists learn to write backwards so they can label a plastic dish on the bottom side, flip it right side up and see your identifiers under your embryos on the bottom of the dish. Now you can buy labelers that print identifiers on plastic adhesive strips that you can stick to the bottom of the dish which accomplish the same thing and doesn’t rely on the embryologist’s penmanship.

Regardless of your labeling method, you still have to be sure to put the right embryo in the right dish. That’s the reason behind another common lab rule. Only dishes from one case can be worked on at one time. If other case dishes aren’t within reach, it is really hard to grab the wrong dish.

Unfortunately, although there are standards for how things should be done, these standards are voluntary and often provide only general guidance. To become accredited by Joint Commission or the College of American Pathologists (CAP), labs must convince the inspector during and annual or biannual lab inspection that they are adhering to hundreds of lab standards. Labs can choose not to get accreditation although they are looked at critically by the professional community if they do this. Standards are usually not very specific. Instead of saying, label the dish on the bottom, the standard may say, make sure you have a system in place to label samples and prevent mix-ups. Unfortunately, some labs do a bad job of designing smart protocols to meet general standards. Fortunately, most of these safety protocols are common sense. You can ask the questions and listen to the answers. If the answers seem weak to you or poorly thought out, you can move on to another provider.

Questions you can ask your fertility clinic doctor or lab director:

How many embryologists do you have that work on IVF cases? If only one, what happens when they get sick? How are techs covered when one is sick?  (Sometimes programs have two techs but one works only with sperm and not embryos. This approach does not provide a back-up for embryology.)

Tell me about your protocols to prevent lab mix-ups?

Patients sometimes don’t like to ask these questions because they worry that their doctor will think they don’t trust them and won’t like them anymore. But you have a right to ask these questions and see if the answers make you more or less comfortable with the care you are receiving. A good program won’t mind sharing the details with you to reassure you that you are in good hands.

© 2010, Carole. All rights reserved.

6 Responses to this entry

  • Anonymous Says:

    I am a research engineer working for a chemical R&D company, and I keep telling my lab assistant to label the bottom of the container, not the lid! Learnt from my own mistakes 🙂

  • Carole Says:

    Very interesting! I thought only embryologists learned to write backwards on the bottom of dishes!!

  • Anonymous Says:

    oh, i meant label the container, not the lids. it’s hard enough to get my assistant to label, forget about writing backwards 🙂

  • Anonymous Says:

    Being a research scientist myself, i agree that mistakes/accidents happen. Do embryologists typically admit to patients that a mistake or an accident occured with the patient’s eggs/sperm/embryos (such as breaking the egg, as you mentioned in one of your posts)?

    How would the patient know that, for example, her eggs were indeed poor quality, and that the embryologists didn’t mess up something? Would/could they take pictures at all stages of a bad cycle for proof? Thanks!

  • Carole Says:

    Errors and mistakes can occur without any malicious intent. Every patient is asked to give consent before undergoing a medical procedure. A patient can only give informed consent if they are given a full explanation of risks, benefits and alternatives to the procedure they are considering. Any and all risks to eggs, sperm, embryo and the patients themselves are typically disclosed in the consent document. Loss of or damage to the embryos or eggs is usually on this list. Then there is also a blanket warning that other UNKNOWN risks might well exist. If you are fully informed, you can make a good decision about deciding to proceed or saying, “No Thanks”.

    About disclosure: Most (if not all) hospitals have policies regarding the need and requirement to disclose medical errors to patients.Staff are educated regarding their duties to patients. In a private clinic, the medical director would be responsible for policies regarding disclosure of medical errors. Finally, photos may be taken, either for quality assurance or for the patients to have as keepsakes, not in anticipation of having to defend oneself in trial. The bottom line is that you need to feel that you can trust your provider. Some patients need to have a lot of questions answered to earn this trust. Others are happy to go on a recommendation from a friend. When things don’t go as planned, you should feel you can ask your doctor and team to explain what they think is wrong. Sometimes there is no obvious explanation (for say, fragile eggs) – hence unexplained infertility.

  • Anonymous Says:

    Here’s another story of a gross IVF lab mistake.

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